Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab

Sponsor
National Cancer Institute, Naples
Study ID
NCT01706120
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles
  • Paclitaxel — DRUG
    • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles
  • Carboplatin — DRUG
    • Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Study Details

The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.

Key Dates

First listed
Oct 15, 2012
Start date
Oct 31, 2012
Status verified
Mar 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: First-line chemotherapy with bevacizumab
    * Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Primary Outcome Measure

expression of soluble and tissutal biomarkers [ Time Frame: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient ]

Related Studies